COMPARATIVE DISEASE BURDEN IN PATIENTS WITH RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS OR ANKYLOSING SPONDYLITIS: DATA FROM COVAD PATIENT-REPORTED E-SURVEY

BackgroundRheumatoid arthritis (RA) and spondyloarthritis, including either Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS), are some of the most diagnosed autoimmune rheumatic diseases (AIRDs) in rheumatologists' routine clinical practice [1]. Understanding patients' health and functional status is crucial to provide personalized management strategies to optimize disease control and enhance the quality of life.ObjectivesWe aimed to compare disease burden in patients with RA, PsA or AS by assessing Patient-Reported Outcome Measurement Information System (PROMIS) Physical Health, Global Mental Health, Physical Function and Fatigue 4a together with VAS Pain.MethodsData were obtained in the international COVID vaccination in autoimmune rheumatic diseases study second e-survey (COVAD study). Demographics, AIRD diagnosis, disease activity, PROMIS Global Physical health, PROMIS Global Mental Health, PROMIS Physical Function SF10 and PROMIS Fatigue 4a score were extracted from the COVAD study database. For this study, we only included patients with self-reported RA or spondyloarthritis (either PsA or AS) undergoing active treatment with conventional synthetic disease-modifying drugs (DMARDs) and/or biologic DMARDs, who answered all the survey questions. Active disease was defined as the patient's perception of their disease as active in the four weeks before their first COVID-19 vaccine shot. Analysis of Variance with Bartlett's and Tukey's test was used to compare continuous variables between groups.ResultsFrom January to June 2022, n.1907 patients with RA, female 87.62% (1671/1907), with mean age (±SD) 50.95 ±13.67, n.311 patients with PsA, female 67.20% (209/311), with a mean age of 50.42 ±12.70, and n.336 patients with AS, male 51.31% (209/311), with a mean age of 43.13 ±12.75 years, responded to the COVAD e-survey.In those with active disease, neither physical health, global mental health, physical function, fatigue, nor pain were different among groups (Table 1, Figure 1). Patients with inactive AS had higher mean global physical health scores than RA patients (13.13 ±2.93 VS RA 12.48 ±2.90, p=0.01, Table 1). Those with inactive RA or PsA showed more severe fatigue (PsA 10.58 ±2.22, RA 10.45 ±4.08 VS 9.4 ±4.13, p =0.01 for both). Patients with inactive RA also reported poorer physical function and more residual pain than those with AS (37.79 ±8.86 VS 41.13 ±7.79, p<0.001;3.87 ±2.45 VS 3.34 ±2.39, p=0.01, respectively). Similarly, residual pain was perceived as higher in patients with inactive PsA than those with AS (4.04 ±2.50 VS 3.34 ±2.39, p=0.01)ConclusionDisease burden is roughly comparable in patients with active RA, PsA or AS. Patients with inactive RA and PsA suffer higher disease burden than those with inactive AS.Reference[1]Mease PJ, Liu M, Rebello S, Kang H, Yi E, Park Y, Greenberg JD. Comparative Disease Burden in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis: Data from Two Corrona Registries. Rheumatol Ther. 2019 Dec;6(4):529-542.Table 1.Patient-Reported Outcome Measures between groups.Inactive diseaseAS (n.185)PsA (n.179)RA (n.1167)MeanSDMeanSDMeanSDPROMIS Global Physical Health13.13*2.9512.433.2712.482.90p=0.01, VS RAPROMIS Global Mental Health13.313.3612.973.3312.843.17PROMIS Fatigue 4a9.44.1310.58*4.2210.45*4.08p=0.01, bothPROMIS Physical Function SF10 Score41.137.3939.279.0137.79*8.86p<0.001, VS ASVAS Pain3.342.394.04*2.503.87*2.45p=0.01, bothActive DiseaseAS (n.35)PsA (n.38)RA (n.189)MeanSDMeanSDMeanSDPROMIS Global Physical Health11.053.1910.102.7611.243.41PROMIS Global Mental Health11.313.2610.843.6311.893.30PROMIS Fatigue 4a12.944.8712.844.4211.754.68PROMIS Physical Function SF10 Score35.829.6233.528.7634.909.80VAS Pain4.682.775.02.544.682.61Figure 1.Violin plots showing kernel densities, quartiles and median for Patient-Reported Outcome Measures for patients with RA, PsA and AS, stratified by disease activity status.[Figure omitted. See PDF]Acknowledgements:NIL.Disclosure of InterestsVincenzo Venerito: None declared, Marc Fornaro: None declared, Florenzo Iannone: None declared, Lorenzo Cavagna: None declared, Masataka Kuwana: None declared, Vishwesh Agarwal: None declared, Naveen Ravichandran: None declared, Jessica Day Grant/research support from: JD has received research funding from CSL Limited., Mrudula Joshi: None declared, Sreoshy Saha: None declared, Syahrul Sazliyana Shaharir: None declared, Wanruchada Katchamart: None declared, Phonpen Akarawatcharangura Goo: None declared, Lisa Traboco: None declared, Yi-Ming Chen: None declared, Parikshit Sen: None declared, James B. Lilleker Speakers bureau: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Consultant of: JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript., Arvind Nune: None declared, John Pauling: None declared, Chris Wincup: None declared, Ai Lyn Tan Speakers bureau: ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Nelly Ziade Speakers bureau: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Grant/research support from: NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre;none are related to this manuscript, Marcin Milchert: None declared, Abraham Edgar Gracia-Ramos: None declared, Carlo Vinicio Caballero: None declared, COVAD Study: None declared, Vikas Agarwal: None declared, Rohit Aggarwal Speakers bureau: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Grant/research support from: RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, and Roivant., Latika Gupta: None declared.

PLACEBO-CONTROLLED EFFICACY AND SAFETY OF UPADACITINIB THROUGH ONE YEAR IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

BackgroundUpadacitinib (UPA), a Janus kinase inhibitor, was effective and well tolerated in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) through 14 weeks (wks) of treatment.[1]ObjectivesThis analysis assessed the efficacy and safety of UPA vs placebo (PBO) through 1 year.MethodsThe SELECT-AXIS 2 nr-axSpA study included a 52-wk randomized, double-blind, PBO-controlled period. Enrolled adults had a clinical diagnosis of active nr-axSpA fulfilling the 2009 ASAS classification criteria, objective signs of inflammation based on MRI sacroiliitis and/or elevated C-reactive protein, and an inadequate response to NSAIDs. One-third of pts had an inadequate response to biologic DMARDs. Pts were randomized 1:1 to UPA 15 mg once daily or PBO. Concomitant medications, including NSAIDs, had to be kept stable through wk 52. The study protocol outlined that pts who did not achieve ASAS20 at any two consecutive study visits between wks 24 to 52 should receive rescue therapy with NSAIDs, corticosteroids, conventional synthetic/biologic DMARDs, or analgesics. Cochran-Mantel-Haenszel (CMH) test with non-responder imputation incorporating multiple imputation (NRI-MI) was used to handle missing data and intercurrent events for binary efficacy endpoints. Mixed-effect model repeated measures (MMRM) was used to assess continuous efficacy endpoints. NRI was used for binary endpoints after rescue and as observed analysis excluding data after rescue for continuous endpoints. Treatment-emergent adverse events (TEAEs) are reported through wk 52.ResultsOf the 314 pts randomized, 259 (82%;UPA, n=130;PBO, n=129) completed wk 52 on study drug. More pts achieved an ASAS40 response with UPA vs PBO from wks 14 to 52 with a 20% treatment difference at wk 52 (63% vs 43%;nominal P <.001;Figure 1). The proportion of pts achieving ASDAS inactive disease with UPA remained higher than PBO at wk 52 (33% vs 11%;nominal P <.0001;Figure 1). Consistent improvements and maintenance of efficacy were also seen across other disease activity measures. Between wks 24 and 52, fewer pts on UPA (9%) than PBO (17%) received rescue therapy. A similar proportion of pts in each treatment group had a TEAE (Table 1). Infections were the most common TEAE;the rates of serious infections and herpes zoster were higher with UPA vs PBO, although no new serious infections were reported from wks 14 to 52. COVID-19 events were balanced between treatment groups. No opportunistic infections, malignancy excluding non-melanoma skin cancer, adjudicated major adverse cardiovascular events, inflammatory bowel disease, or deaths were reported. Two pts (1.3%) on PBO had adjudicated venous thromboembolic events.ConclusionUPA showed consistent improvement and maintenance of efficacy vs PBO through 1 year across multiple disease activity measures. No new safety risks were identified with longer-term UPA exposure. These results continue to support the benefit of UPA in pts with active nr-axSpA.Reference[1]Deodhar A, et al. Lancet. 2022;400(10349):369–379.Table 1.Safety through week 52Event, n (%)PBO (n = 157)UPA 15 mg QD (n = 156)Any AE103 (66%)107 (69%)Serious AE6 (3.8%)6 (3.8%)AE leading to D/C4 (2.5%)6 (3.8%)COVID-19-related AE22 (14%)24 (15%)Deaths00Infection60 (38%)68 (44%) Serious infection1 (0.6%)2 (1.3%) Herpes zoster1 (0.6%)5 (3.2%)Malignancy other than NMSC00NMSC1 (0.6%)0Hepatic disorder7 (4.5%)6 (3.8%)Neutropenia1 (0.6%)8 (5.1%)MACE (adjudicated)00VTE (adjudicated)2 (1.3%)a0Uveitisb3 (1.9%)2 (1.3%)Inflammatory bowel disease00aBoth patients had non-serious events of deep vein thrombosis in the lower limb with risk factors including obesity and prior deep vein thrombosis in one patient and concomitant COVID-19 infection in the other patient.bThree events of uveitis occurred in each treatment group (among n = 3 patients in the PBO group and n = 2 patients in the UPA group);two events in the PBO group and one in the UPA group occurred in patients with a history of uveitis.AcknowledgementsAbbVie funded this study and participated in the study design, res arch, analysis, data collection, interpretation of data, review, and approval of the . All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsFilip van den Bosch Speakers bureau: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Consultant of: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, and Pfizer., Walter P Maksymowych Consultant of: AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB, Employee of: Director of Imaging Rheumatology BV, Tae-Hwan Kim Speakers bureau: AbbVie, Celltrion, Kirin, Lilly, and Novartis., Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi Sankyo, Eisai, Gilead, Janssen, Lilly, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB., Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie and Novartis, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Kristin D'Silva Shareholder of: AbbVie, Employee of: AbbVie, Peter Wung Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie.

ANTI-TNF TREATMENT MODIFIES PAIN MODULATION DESCENDING PATHWAYS. A PROSPECTIVE, 6 MONTHS STUDY IN ACTIVE CHRONIC INFLAMMATORY RHEUMATISM PATIENTS' NAÏVE OF BDMARD

BackgroundIn rheumatoid arthritis (RA) and spondyloarthritis (Spa), persistent pain remains challenging. In active disease, diffuse noxious inhibitory controls (assessed through conditioned pain modulation (CPM)) are impaired [1]. Little is known regarding impairment of pain pathways in patients under bMDARD.ObjectivesThe main objective of the RAPID (Rheumatism Pain Inhibitory Descending pathways) study, was to assess descending pain modulation (through CPM paradigm) in patients with active RA or Spa, after introduction of first bDMARD with anti-TNF.MethodsWe included 50 RA and 50 Spa patients with active disease, naïve of bDMARD. We assessed clinical disease variables for patients, together with responses to various psychological questionnaires. All participants underwent QST with the determination of heat and cold pain thresholds (HPT-CPT) on dominant forearm and CPM. CPM paradigm require a conditioning stimulus, here applied to the non-dominant foot (cold circulating bath at 8°C during 1min). Descending pain control was assessed as the change in HPT (in °C) following the conditioning stimulus: the higher the CPM effect, the more efficient the inhibitory control. Patients were followed at 3 and 6 months after TNF inhibitor initiation. At both follow-up visits, clinical monitoring of the rheumatism and repeated thermal QST and CPM.ResultsOne hundred patients were included, 59 women, mean age 45.8 (± 14.6) and mean disease duration 7.93 (± 7.96) years. Due to COVID surge 87 patients initiated an anti-TNF, 74 patients completed the follow-up. At 6 months, 40 patients achieved a good therapeutic response (good EULAR response or ASDAS major improvement), 19 patients had a moderate therapeutic response (moderate EULAR response or clinically important improvement) and 15 patients had no therapeutic response. At the end of follow-up, 51 patients were in remission or low disease activity and 47 patients had a pain intensity <4/10. Thermal pain thresholds did not significantly change during follow-up. Mean HPT was at beaseline 42.35°C (+/- 3.68) and at 6 months 42.17°C (+/- 3.67). Mean CPT was at baseline 13.11°C (+/- 10.04) and at 6 months 12.86°C (+/- 9.45). Conditioned pain modulation was significantly changed during follow-up. Mean CPM effect was at baseline 0.25°C (±2.57), 2.64°C (±2.12) at 3 months and 2.96°C (±2.50) at 6 months. At the end of the 6 months follow-up, mean CPM effect was significantly higher in patients with residual mean pain intensity <4/10 compared to patients with persisting pain ≥ 4/10: 3,25°C (± 2,68) vs 2,47 (± 2,11) (p=0.04).ConclusionAfter TNF inhibitor initiation in active RA or SpA, impaired diffuse noxious inhibitory controls are significantly improved. Apart from their articular efficacy, TNF inhibitor have an action on the central nervous system and pain modulation pathways. In patients with persisting pain under bDMARD, diffuse noxious inhibitory controls are not as efficient as patient without residual pain.Reference[1]Trouvin AP, Simunek A, Coste J, Medkour T, Carvès S, Bouhassira D, Perrot S. Mechanisms of chronic pain in inflammatory rheumatism: the role of descending modulation. Pain. 2022 Aug 3. doi: 10.1097/j.pain.0000000000002745.Figure 1.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

CHARACTERISTICS OF PATIENTS WHO RECEIVED BIOLOGICAL TREATMENT AFTER KIDNEY TRANSPLANTATION AND THE INCIDENCE OF SERIOUS INFECTIONS: A MULTICENTER STUDY

BackgroundKidney transplant patients due to both primary kidney involvement of chronic/autoimmune inflammatory diseases and end-stage kidney disease related to amyloidosis are followed up in rheumatology clinics. Biological agents one of the treatment options in kidney transplant recipients with chronic/autoimmune inflammatory disease.ObjectivesHowever, there is insufficient data on the development of infection in kidney transplant recipients who received biological treatment. Herein, we aimed to determine the incidence of serious infections in patients with kidney transplant recipients who are received biological therapy.MethodsKidney transplant recipients who are received biological agents due to rheumatologic disease were included in the study. Patients' demographic features, transplantation data, biological treatment, development of infection and severity of infection were screened retrospectively. Infections that requiring hospitalization were defined as severe infections.ResultsA total of 31 patients were included in the study, 14 (45%) of whom were female and mean age was 41 ±9 years. Twenty-five patients (80%) of them were non-preemptive kidney transplant and mean duration of hemodialysis before the transplantation was 40 ±40 months. Twenty-three patients (74%) had end stage kidney failure due to FMF-amyloidosis(Figure-1-). Seventeen patients (54%) received anakinra, 11 patients (35%) received canakinumab and 3 patients (10%) received etanercept with other immunosuppressive treatment. Mean treatment duration of biological agents was 4.2±2.6 years. Two patients developed solid organ malignancy and one patient developed hematological malignancy after transplantation. Sixteen of the patients (52%) were hospitalized at least once due to infection and 4 patients (13%) died due to infection. The cause of decease in two patients was COVID-19.ConclusionRheumatic diseases are an important cause of end-stage renal disease and definitive treatment is kidney transplantation. Kidney transplant recipients due to rheumatological disease also use biological agents in the post-transplantation period. Kidney transplant recipients have higher risk for the development of infection since they receive immunosuppressive therapy and use of biologic agents may further increase the risk for development infection. Meyer et al reported that infection developed in 54 of 187 solid organ transplant recipients using biological agents.[1] Mean treatment duration of biological agents was 12 months in this study. The incidence of infection was 54% in our study. Mean treatment duration of biological agent was 4.2 year was considered main reason for higher incidence of infection in our study.Reference[1]Meyer F, Weil-Verhoeven D, Prati C, Wendling D, Verhoeven F. Safety of biologic treatments in solid organ transplant recipients: A systematic review. Semin Arthritis Rheum. 2021 Dec;51(6):1263-1273. doi: 10.1016/j.semarthrit.2021.08.013. Epub 2021 Aug 26. Erratum in: Semin Arthritis Rheum. 2022 Aug;55:152015. PMID: 34507811.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

BERTOLOTTI SYNDROME: AN UNDER RECOGNIZED CAUSE OF INFLAMMATORY BACK PAIN?

BackgroundBertolotti syndrome describes a lumbosacral transitional vertebra (LSTV) which causes symptoms, usually low back pain. LATV is a congenital anomaly where the L5 vertebra has an unusual morphology. Bertolotti syndrome is an under-recognised condition by clinicians.ObjectivesTo clarify the presentation of Bertolotti syndrome, whether there are features of inflammatory back pain (IBP) and the effect on quality of life.MethodsIn this pilot study, 62 patients with LSTV were identified on imaging (plain x-ray). Imaging was performed for a variety of indications, predominently for back pain. In total, 34 patients agreed to take part, with 18 returning questionnaires. Questionnaires were selected for face vailidity and included: Calin IBP Questionnaire, EQ-5D Questionnaire, Visual analogue pain scale (VAS-P). In view of Covid restrictions all contact was by phone and questionnaires were completed online or returned via post.Plain X-rays visualising the lumbar spine were assessed for radiological features of LSTV.ResultsSeventeen (94%) of the participants (n=18) recorded a VAS-P score >3, indicating a clinically significant level of pain. The mean VAS-P score was 6 (range of 2-9). 89% of respondents scored at least 3/5 in the Calin questionnaire. Of the 5 features of inflammatory back pain in the Calin questionnaire, 4 out of the 5 were reported by most respondents. The exception was ‘improvement on exercise', which was only reported by 18% of respondents. Quality of life was impaired-EQ-5D (mean: 0.503, range -0.074 to 0.796).The commonest radiological abnormality was enlarged transverse process (100%) followed by pseudoarticulation with the sacrum (83%) and scoliosis (33%). Presence of sclerosis and/or osteoarthritis at the pseudoarticulation was associated with worse pain scores. Female respondents reported worse pain.ConclusionThese results suggest Bertolotti syndrome is associated with pain in the majority of patients and affects quality of life,. The character and site of the pain suggests that Bertollotti syndrome should be considered in the differential diagnosis of spondyloarthritis.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsSimon Stebbings Consultant of: Abbvie.Janssen, Ciara White: None declared, Terence Doyle: None declared.

SAFETY OF BIVALENT SARS-COV-2 VACCINES AS A SECOND BOOSTER DOSE IN ARTHRITIS PATIENTS ON IMMUNOSUPPRESSIVE THERAPIES

BackgroundSafety and efficacy of updated bivalent vaccines, containing both the original vaccine variant of SARS-CoV-2 Spike and either Omicron variants BA.1 or BA.4/5, are of particular interest in arthritis patients on immunosuppressive therapies. With the continuous emergence of new viral variants, it is important to evaluate whether updated vaccines induce more adverse events in this patient group.ObjectivesTo examine if a second booster dose with updated bivalent vaccine increases the risk of adverse events, compared to the first booster dose with monovalent vaccines.MethodsThe prospective Nor-vaC study investigates vaccine responses in patients with immune mediated inflammatory diseases using immunosuppressive therapies (1). The present analyses included arthritis patients who received two booster doses. Patients received available vaccines according to the Norwegian vaccination program. The current recommendation in the Norwegian arthritis population is a three-dose primary vaccination series followed by two booster doses. Adverse events following vaccines doses were self-reported through questionnaires. Adverse events following the first (monovalent) and second (bivalent) booster were compared with McNemar's test.ResultsBetween 7th of July 2021 and 6th of December 2022 a total of 243 arthritis patients (127 rheumatoid arthritis, 65 psoriatic arthritis, 51 spondyloarthritis) on immunosuppressive therapies (Table 1) received a first, monovalent (BNT162b2, mRNA-1273) and a second, bivalent booster dose (BNT162b2 (WT/OMI BA.1), mRNA-1273.214, BNT162b2 (WT/OMI BA.4/BA.5)). Adverse events were recorded within 2 weeks in all patients (Figure 1). In total, 45 vs 49 (19% vs 20 %) patients reported any adverse event after a second, bivalent booster dose, compared to the first, monovalent booster, respectively. There was no significant difference in adverse events overall (p= 0.57). The most common adverse events after the second booster were pain at injection site (12 %), flu-like symptoms (9 %) and headache (6 %). No new safety signals emerged. A total of 15 (6 %) patients reported a disease flare after receiving the second, bivalent booster, compared to 21 (8 %) after the first, monovalent booster.ConclusionThere was no difference in adverse events between the monovalent, first booster, and the bivalent, second booster, indicating that bivalent vaccines are safe in this patient group.Reference[1]Syversen S.W. et al Arthritis Rheumatol 2022Table 1.Demographic characteristics and immunosuppressive medication in patients receiving a 1st monovalent and a 2nd bivalent booster dose.CharacteristicsPatients, n (%)Total243Age (years), median (IQR)61 (52-67)Female152 (63)Immunosuppressive medicationTNFi monoa75 (31)TNFi comboa+b72 (30)Methotrexate62 (26)Rituximab9 (4)IL-inhibitorsc6 (2)JAK-inhibitorsd11 (5)Othere8 (3)1st boosterBNT162b2106 (44)mRNA-1273137 (56)2nd boosterBNT162b2 (WT/OMI BA.1)65 (25)BNT162b2 (WT/OMI BA.4/BA.5)120 (47)mRNA-1273.214 (WT/OMI BA.1)58 (23)Results in n (%) unless otherwise specified.aTumor necrosis factor inhibitors: infliximab, etanercept, adalimumab, golimumab, certolizumab pegol.bCombination therapy: methotrexate, sulfasalazine, leflunomide, azathioprine.cInterleukin inhibitors: tocilizumab, secukinumab.dJanus kinase inhibitors: filgotinib, baricitinib, upadacitinib, tofacitinib.eOther: abatacept, sulfasalazine, leflunomide, azathioprine.Figure 1.Adverse events after bivalent vaccine as a 2nd booster dose compared to a monovalent vaccine as a 1st booster dose.[Figure omitted. See PDF]AcknowledgementsWe thank the patients and health-care workers who have participated in the Norwegian study of vaccine response to COVID-19. We thank the patient representatives in the study group, Kristin Isabella Kirkengen Espe and Roger Thoresen. We thank all study personnel, laboratory personnel, and other staff involved at the clinical departments involved, particularly Synnøve Aure, Margareth Sveinsson, May Britt Solem, Elisabeth Røssum-Haaland, and Kjetil Bergsmark.Disclosure of InterestsHilde Ørbo: None declared, Ingrid Jyssum: None declared, Anne Therese Tveter: None declared, Ingrid E. Christensen: None declared, Joseph Sexton: None declared, Kristin Hammersbøen Bjørlykke Speakers bureau: Janssen-Cilag, Grete B. Kro: None declared, Tore K. Kvien Speakers bureau: Amgen, Celltrion, Egis, Evapharma, Ewopharma, Hikma, Oktal, Sandoz, Sanofi, Consultant of: AbbVie, Biogen, Celltrion, Eli Lilly, Gilead, Mylan, Novartis, Pfizer, Sandoz, Sanofi, Grant/research support from: AbbVie, Amgen, BMS MSD, Novartis, Pfizer, UCB, Ludvig A. Munthe Speakers bureau: Novartis, Cellgene, Gunnveig Grodeland Speakers bureau: Bayer, Sanofi, ThermoFisher, Consultant of: AstraZeneca, Siri Mjaaland: None declared, John Torgils Vaage: None declared, Espen A Haavardsholm Speakers bureau: Pfizer, UCB, Consultant of: AbbVie, Boehringer-Ingelheim, Eli Lilly, Gilead, Kristin Kaasen Jørgensen Speakers bureau: Bristol-Myers Squibb, Roche, Sella Aarrestad Provan: None declared, Silje Watterdal Syversen: None declared, Guro Løvik Goll Speakers bureau: AbbVie/Abbott, Galapagos, Pfizer, UCB, Consultant of: AbbVie/Abbott, Galapagos, Pfizer, UCB.

ACCELERATED WANING OF HUMORAL IMMUNE RESPONSE TO A THIRD COVID-19 VACCINATION IN PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES

BackgroundA 3rd COVID-19 vaccination is currently recommended for patients under immunosuppression. However, a fast decline of antibodies against the SARS-CoV-2 receptor-binding domain (RBD) of the spike protein has been observed.ObjectivesIt remains unclear whether immunosuppressive therapy affects kinetics of humoral and cellular immune responses.Methods50 patients under immunosuppression and 42 healthy controls (HCs) received a 3rd dose of an mRNA-based vaccine and were monitored over a 12-weeks period. Humoral immune response was assessed 4 and 12 weeks after 3rd dose. Antibodies were quantified using the Elecsys Anti-SARS-CoV-2 Spike immunoassay against the receptor-binding domain (RBD) of the spike protein. SARS-CoV-2-specific T cell responses were quantified by IFN-γ ELISpot assays. Adverse events, including SARS-CoV-2 infections, were monitored over a 12-week period.ResultsAt week 12, reduced anti-RBD antibody levels were observed in IMID patients as compared to HCs (median antibody level 5345 BAU/ml [1781 – 10208] versus 9650 BAU/ml [6633 - 16050], p < 0.001). Reduction in relative antibody levels was significantly higher in IMID patients as compared to HCs at week 12 (p < 0.001). Lowest anti-RBD antibody levels were detected in IMID patients who received biological diseases modifying anti-rheumatic drugs (DMARDs) or a combination therapy with conventional synthetic and biological DMARDs. Number of SARS-CoV-2-specific T cells against wildtype and Omicron variants remained stable over 12 weeks in IMID patients. No serious adverse events were reported.ConclusionDue to a fast decline in anti-RBD antibodies in IMID patients an early 4th vaccination should be considered in this vulnerable group of patients.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsDaniel Mrak Consultant of: AstraZeneca, Felix Kartnig: None declared, Daniela Sieghart: None declared, Elisabeth Simader Speakers bureau: Lilly, Helga Radner Speakers bureau: Gilead, Merck Sharp and Pfizer, Peter Mandl: None declared, Lisa Göschl: None declared, Philipp Hofer: None declared, Thomas Deimel: None declared, Irina Gessl: None declared, Renate Kain Speakers bureau: Otsuka, Consultant of: AstraZeneca, Takeda Pharma, MEDahead and Janssen Cilag, Stefan Winkler: None declared, Josef S. Smolen Consultant of: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celltrion, Gilead-Galapagos, Janssen, Lilly, Pfizer, R-Pharma, Samsung, Sanofi, Chugai, Merck Sharp & Dohme, Novartis-Sandoz Roche, Samsung and UCB, Grant/research support from: Abbvie, AstraZeneca, Lilly, Novartis, and Roche, Thomas Perkmann: None declared, Helmuth Haslacher Grant/research support from: Glock Health, BlueSky Immunotherapies and Neutrolis, Daniel Aletaha Speakers bureau: Abbvie, Amgen, Galapagos, Lilly, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Consultant of: Abbvie, Amgen, Galapagos, Lilly, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Grant/research support from: Abbvie, Amgen, Galapagos, Lilly, Janssen, Merck, Novartis, Pfizer, Sandoz, and Sanofi, Leonhard Heinz: None declared, Michael Bonelli Consultant of: EliLilly.

CLINICAL COURSE IN COVID 19 DISEASE IN IMMUNOSUPRESSED PATIENTS DIAGNOSED WITH RHEUMATIC DISEASES

BackgroundPatients with pre-existing rheumatic diseases may be exacerbated during SARS-CoV-2 infection, or may develop new autoimmune features. Furthermore, immunosuppressive agents used to treat autoimmunity-inflammation as well as comorbidities can also affect the disease outcome.ObjectivesTo evaluate the outcome of rheumatic diseases after Covid 19 infection in patients diagnosed with rheumatic diseases, under various immunosuppressive treatment, as well as the effects of vaccines against Covid or antiviral treatment in this sensitive population group.MethodsDuring the pandemic, 1493 patients with autoimmune or autoinflammatory disease who were continuously followed up in two tertiaries hospitals in northern and northwestern Greece were included in the current study. The patients were compared with 769 controls after adjustment for age, sex, weight, vaccination status and comorbidities. Of the 1493 patients, 648 had rheumatoid arthritis, 282 psoriatic arthritis, 173 ankylosing spondylitis, 122 systemic lupus erythematosus, 98 Sjogren's syndrome, 43 polymyalgia rheumatica, 34 mixed connective tissue disease or overlapping syndromes, 31 vasculitis, 27 systemic sclerosis, 18 myositis, 10 Behcet syndrome, 5 primary antiphospholipid syndrome and 2 had Familial Mediterranean Fever. The vast majority of patients and controls were fully vaccinated (82%) and 397 patients received antiviral treatment, 94% of them were fully vaccinated.ResultsCovid 19 disease in vaccinated patients with rheumatic diseases was shown to perform the same or about the same as those in the control group after adjustment for risk factors for severe disease. 19 of our patients required admission in the intensive care unit (62% full vaccinated) while a total of 12 died (66% non vaccinated). Major risk factors for severe disease were previous respiratory failure, chronic renal impairment, obesity, and failure to receive antiviral therapy. It was also shown that infection with Covid led to an exacerbation or induction of autoimmune disorders in 25 of the participants.ConclusionIn this large cohort, Covid 19 disease was shown to affect patients with autoimmune rheumatic diseases the same or approximately the same way as the general population if they are fully vaccinated and if they start timely antiviral treatment where indicated. Further research and monitoring of the results after the multiple mutations of the virus is advisable.ReferencesNone.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

EVALUATION OF TELENURSING FOLLOW-UP IN A COHORT OF STABLE/LOW DISEASE ACTIVITY PATIENTS WITH INFLAMMATORY ARTHRITIDES: A FEASIBILITY STUDY

BackgroundPeriodic follow-up (FU) is necessary for patients with Rheumatic Diseases (RDs). In the case of a stable clinical condition or low disease activity, FU can be carried out also by rheumatology nurses (RNs). Recent studies focusing on FUs led by RNs either in Rheumatology Clinics and with Telenursing (TN), showed promising results in terms of outcomes, cost reduction and users' satisfaction.ObjectivesTo evaluate the feasibility of a Telenursing FU in a Rheumatology Centre in Florence, Italy.MethodsIn this pilot study, patients with stable inflammatory arthritis or low disease activity were contacted, after their first visit, through TN (T0) and then assessed during the following in-person visit (V12) by RNs for treatment adherence, for pain, for mental and physical health, for workability, for perception of disease activity and satisfaction concerning the TN service.ResultsOut of 27 interviewed patients, 59.3% (n=16/27) was affected by Rheumatoid Arthritis (RA), 18.5% (n=5/27) by Spondyloarthritis (AS), 14.8% (n=4/27) by Psoriatic Arthritis (PsA) and 7.4% (n=2/27) by Juvenile Idiopathic Arthritis. The mean age was 57.5±13.1 (M± DS) years and the treatment adherence level was optimal. 11.1% (n=3/27) of patients was referred for medical consultation because of the urgent clinical situation assessed by the RNs according to the clinical multidisciplinary checklist. After specialist consultation, 1 patient was revalued in presence for a transient ischemic attack;1 patient was contacted by the rheumatologist following independent discontinuation of methotrexate therapy;1 patient was redirected to urgent dermatology consultation because of a suspected cutaneous drug reaction.During the TN period (12 months), 33.3% (n=9/27) of the patients contracted SARS-CoV-2 infection and 11.1% (n=3/27) contracted urinary or upper respiratory tract infections.RA patients showed a mean Rheumatoid Arthritis Impact of Disease-RAID score of 2.4 at T0 and 2.5 at V12 (Range 0-10);AS patients showed a mean Assessment of Spondyloarthritis International Society-ASAS score of 0.3 in both periods and PsA showed a mean Psoriatic Arthritis Impact of Disease-PSAID score of 0.7 and 0.8 at T0 and V12, respectively. Among RA, AS and PsA patients, as a pain score of 3 was recorded in both periods.In order to attend the in-person FU visit, 68.4% (n=13/19) of the patients took work leave. 37% (n=10/27) of them waited 40.9±18.6 minutes at V12 control. The average distance between the Rheumatology Centre and patients' home was 29.3±25.6 km. 15.4% (n=5/13) of the respondents did not own a car and 23.1% (n=3/13) was accompanied to visit by their caregiver.All the included patients expressed high satisfaction for the TN service, corresponding to 5 point Likert scale.ConclusionThe data show that TN FU is a valuable model for maintaining an adequate level of therapeutic adherence, reducing the travel time and working day loss, intercepting remotely clinical issues, as well as registering a high level of user acceptance and satisfaction. Further studies on larger samples are needed to confirm our findings.References[1] Bech B et al (2020) 2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Annals of the Rheumatic Diseases;79:61-68. doi: 10.1136/annrheumdis-2019-215458.[2] Alcazar B, Ambrosio L. (2019) Tele-nursing in patients with chronic illness: a systematic review. An Sist Sanit Navar;42(2):187-197. doi: 10.23938/ASSN.0645.[3] Larsson I et al. (2013) Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy. Journal of Advanced Nursing;70(1), 164–175., 2013 doi:10.1111/jan.12183Acknowledgements:NIL.Disclosure of InterestsNone Declared.

EVALUATION OF PATIENT SATISFACTION WITH REMOTE SELF-INJECTION TRAINING: A SINGLE-CENTRE PATIENT-REPORTED SURVEY

BackgroundSubcutaneous self-injection of methotrexate (SC MTX) is used for the treatment of several inflammatory diseases. All newly initiated patients should be educated and trained in the proper injection technique by their healthcare provider (HCP), with the first injection performed under medical supervision. This training has typically been conducted during face-to-face consultations, however since the start of the COVID-19 pandemic it has been necessary to conduct training remotely due to the cancellation of clinics.ObjectivesTo understand patient-reported experiences and satisfaction with remote SC MTX self-injection training.MethodsA cross-sectional electronic survey was administered between 11 October 2022 and 30 November 2022 to patients at Southern Health and Social Care Trust who had recently been trained via telephone or video conference [VC] on how to self-inject methotrexate using a pre-filled, auto-injector pen. Patients were aged ≥18 with a range of arthritis types, including rheumatoid, psoriatic, polyarticular juvenile idiopathic and chronic reactive inflammatory arthritis. Remote training was delivered by the patient's nurse as per routine practice (independently of this survey). Patients were sent a patient information pack (PIP) prior to the training consultation. During the training, the nurse discussed the process of injecting with the auto-injector pen before virtually supervising the first injection.The survey consisted of 14 questions;topics included experiences and satisfaction with preparation for the HCP appointment, the training consultation itself and post-training experiences and preferences. The responses were analysed descriptively on an item-by-item basis.ResultsIn total 73 patients completed the survey;77% (n=56/73) were female, and 96% (n=70/73) had no prior experience with a SC MTX auto-injector pen. The training was completed by telephone for 92% (n=67/73) of patients and by VC for 8% (n=6/73). 99% (n=72/73) received a PIP in advance of their training consultation and 92% (n=67/73) received this by post. 67% (n=49/73) of patients strongly agreed and 26% (n=19/73) agreed that they felt prepared for the training after receiving the PIP;78% (n=57/73) of patients strongly agreed and 22% (n=16/73) agreed that it was easy to read and understand, whilst 52% (n=38/73) strongly agreed and 32% (n=23/73) agreed that the PIP was helpful and did not require additional instructions before the appointment. 84% (n=61/73) took 15 minutes or less to complete the training with their HCP. None of the participants felt confused or did not understand the training instructions from their HCP, 78% (n=57/73) strongly agreed and 19% (n=14/73) agreed that the remote training was helpful and made them feel more confident to use the injector pen on their own and 97% (n=71/73) did not need to contact their HCP for more training or advice following their appointment. When asked about the main advantages of remote training, 32% (n=23/73) agreed it was more convenient, 25% (n=18/73) agreed that it was time saving and 30% (n=22/73) agreed that not having to attend the hospital was beneficial. 85% (n=62/73) strongly agreed and 14% (n=10/73) agreed that they were satisfied with the remote training provided and 82% (n=60/73) strongly agreed and 18% (n=13/73) agreed that they would recommend the remote training to another patient.ConclusionThese findings provide new insight into patients' experiences with self-injection training when delivered remotely by their HCP. The patient information pack and training consultation were well received as most patients found it helpful, convenient and time saving.References:NIL.AcknowledgementsThis survey was funded by Nordic Pharma. Medical writing support was provided by Angie Bonsu of Open Health and funded by Nordic Pharma.Disclosure of InterestsShannon McCourt Grant/research support from: Nordic Pharma, Mano Andiappan Employee of: Open Health who were paid by Nordic Pharma to support the work described in the .

COVID-19 IN PATIENTS WITH INFLAMMATORY ARTHRITIS IN THE VINSCHGAU VALLEY IN SOUTH TYROL

BackgroundFor patients with autoimmune rheumatic diseases, the Covid-19 pandemic carried some implications in addition to those faced by the general population. In particular, the question whether these patients are at increased risk of contracting Covid-19 or have an unfavourable disease course has been and is a matter of concern.In autumn 2020, the population of the Vinschgau valley in South Tyrol, northern Italy was still largely spared from infection with SARS-CoV-2. Accordingly, incidence of the disease in the upcoming winter was anticipated to be high.ObjectivesThis prospective observational study aimed at characterizing Covid-19 infections in a population of patients with inflammatory arthritis (IA) residing in the Vinschgau valley. The study was conceived as companion project to an analogously designed prospective cohort study in the general population of the Vinschgau valley, the CHRIS Covid-19 study.MethodsBetween september and december 2020, IA patients (i.e. previously diagnosed rheumatoid arthritis [RA], psoriatic arthritis [PsA] or peripheral spondyloarthritis [SpA]) residing in the Vinschgau valley (n=394 based on national healthcare system database) were contacted. Those who consented to participate in the study underwent a clinical baseline visit including TJC, SJC, VAS and assessment of RAID, PsAID9 or BASDAI (range 0-10, respectively). In addition, a Covid-19 screening questionnaire was administered. Then, active and/or past infection with SARS-CoV-2 were determined by nasopharyneal swab (PCR) and serum antibody test. In positively tested subjects, Covid-19 disease severity was graded according to WHO criteria (range 0-8, with 0 = no evidence of infection and 8 = death). Patients were followed-up with regular telephone interviews including Covid-19 screening questionnaire and RAID/PsAID/BASDAI for up to 12 months.Results111 patients (72 RA, 29 PsA, 10 SpA) were enrolled (see Table 1 for demographics and comorbidities).A total number of 19 PCR-confirmed SARS-CoV-2 infections in 17 patients (10 RA, 7 PsA) were observed. Mean ± standard deviation 7-day incidence (incident cases/study population) was 0.003 ± 0.007.Fatigue, fever, anosmia and sore throat (present in 57.9%, 47.4%, 42.1% and 36.8% of infections, respectively) were the most frequent symptoms. Median (min-max) disease severity was 2 [1-4]. Two infections led to hospitalization, in one case oxygen supply was necessary. Four infections were asymptomatic (Figure 1).One patient died during follow-up due to pre-existing non-small cell lung cancer.Median absolute difference between post- and pre-infection disease activity was 0.4 and -0.8 for RAID and PsAID, respectively (both markedly below the minimal clinically important difference of 3 and 3.6 points, respectively).ConclusionIncidence of Covid-19 in the analysed cohort of patients with IA was low. Symptoms and comorbidities of SARS-CoV-2-positive IA patients reflected those known from the general population. Covid-19 seemed to have no relevant impact on IA disease activity. Comparison of these preliminary data with those of the general population is planned.Figure 1.Spectrum of clinical symptoms reported by study patients during infection with SARS-CoV-2[Figure omitted. See PDF]Table 1.Demographic data and selected comorbidities of study patients. Age and body mass index (BMI) are given in means ± standard deviation, female sex and comorbidities are given in n (% of column totals).TotalSARS-CoV-2 positiveHospitalized111172Age at inclusion (years)59.7 ± 9.462.5 ± 10.076.3 ± 9.0BMI at inclusion (kg/m2)27.9 ± 17.126.1 ± 3.330.5 ± 1.6Female sex76 (68.5)10 (58.8)1 (50)Active smokers22 (19.8)1 (5.9)0 (0)Arterial hypertension44 (39.6)8 (47.1)2 (50)Diabetes mellitus4 (3.6)1 (5.9)1 (50)Hyperlipidemia27 (24.3)2 (11.8)1 (50)Cardiac arrhythmias12 (10.8)2 (11.8)1 (50)History of cancer5 (4.5)1 (5.9)0 (0)Chronic bronchitis4 (3.6)1 (5.9)0 (0)Asthma3 (2.7%)0 (0)0 (0)Hospitalized in previous 12 months21 (18.9)3 (17.6)0 (0)Surgery with general anaesthesia in previous 12 months11 (9.9)2 (11.8)0 (0)Ack owledgementsThe authors thank Elena Cannavò and the CHRIS study team, whose support was of invaluable importance for the conduction of the study.Disclosure of InterestsNone Declared.

SAFETY ANALYSIS OF JAKINIBS IN REAL CLINICAL PRACTICE IN A COHORT OF 116 PATIENTS

BackgroundJanus kinase inhibitors (JAKinibs) have demonstrated efficacy in the treatment of rheumatoid arthritis (RA) and spondyloarthritis (SpA), although their safety profile continues to be analysed due to the possible increase in adverse events (AEs) in relation to anti-TNFs (mild and severe infections, haematological alterations, thromboembolism, increase in neoplasms).ObjectivesTo evaluate in real clinical practice the AEs of JAKinibs in a cohort of patients with RA and SpA. In addition, adherence and reasons for discontinuation (1st or 2nd failure, AE) are analysed.MethodsObservational study of 116 patients diagnosed with RA or SpA who received treatment with JAKinibis (tofacitinib, baricitinib, upadacitinib) after failure of treatment with different classical synthetic (FAMEsc) or biological (FAMEb) disease-modifying drugs. The following data were analysed: demographic characteristics of the patients, years of disease progression, 1st or 2nd failures and AE.ResultsMean age was 52 years, with Baricitinib being older (60 years -SD 13.6), higher prevalence of females in all groups, and a disease progression time of about 10 years. Mean number of FAMEsc was 1.6 and mean number of FAMEb was 2,3 to Tofacitinib(Tofa), 2,76 to Baricitinib(Bari) and 4,4 to Upadacitinib(Upa). 71 (63%) patients had active corticosteroid therapy. The median treatment time with Tofa was 8.8 months, Bari 9.5 and Upa 2.4 months.Most frequent AEs with Tofa were urinary tract infections(UTI) (11.9%, 7 cases) and headaches (8.47%, 5 cases). There were 3 cases of herpes zoster (5.1%), one of which was recurrent, and 2 cases respectively of tachycardia and gastrointestinal intolerance (3.4%). With Baricitnib, 2(5%) cases of UTI and 2(5%) of influenza A were reported. Most frequent AEs related to Upadacitinb are gastrointestinal intolerance, labialis and facial herpes, anterior uveitis and recurrent UTI, with 1 case for each adverse event. There were 4 success with Baricitinib treatment: 2 due to severe COVID, 1 influenza A and 1 due to stroke. 17 patients had 1st failure to Tofa(28.81%), 8 to Bari20.0%) and 3 to Upa(18.75%);7(11.86%) and 2(5%) patients had 2nd failure to Tofa and Bari respectively, no with Upa.Mean CRP to Tofa-SD 18.9-was 17.19, 20-SD 22.7- to Bari and 24.2-SD 27.40- to Upa. Mean ESR-SD 15.3- was 25.4, -SD 26.4 and 44.3 -SD 32-, respectively. At 6 months, 36(62%) were continuing on Tofa, 22(56%) on Bari and 4(27%) on Upa. At 12 months, 27(46.6%) were still on Tofa and 12 on Bari(30.8%) and no patients were on upa.Table 1.TofaBariUpaMean age496047Male19%18%20%Female81%82%80%Time course of disease(years)81111Permanence 6 months62%56%27%Permanence 12 months46,6%31%0%Patients with corticotherapy62%64%60%Previous biological drugs2,3 SD 22,8 SD 2,34,4 SD 2,9Patients who discontinued the drug62%59%33%Mean CRP at the end of treatment172024Mean end-of-treatment ESR252644Repeated AEsUTI(7) Headache(5) Shingles(3) Nephritic colic(2) Gastrointestinal intolerance(2) Tachycardia(2)UTI(4) Headache(2)Serious AEsShingles (3)Varicella encephalopathy(1) Stroke(1) Shingles (1)1st failure28,8%20%18,7%2nd failure11,9%5%0%SuccessSARS-Cov2(2) Influenza(1) Stroke(1)Figure 1. Months stay pharmacoConclusionMost frequent adverse events with JAKinibs are mild infections, except gastrointestinal complaints with upadacitinib. Serious adverse events, including 3 deaths from viral infections, were observed, mostly in patients over 65 years. Most frequent cause of discontinuation was treatment failure. We believe that further observational studies are needed to stratify and profile the risk of infection with JAKinibs.References[1]Atzeni F, Popa CD, et al. Safety of JAK inhibitors: focus on cardiovascular and thromboembolic events. Expert Rev Clin Immunol. 2022 Mar;18(3):233-244. Doi: 10.1080/1744666X.2022.2039630 Epub 2022 Feb 17.PMID: 35129033[2]Alves C, Penedones A,et al. The Risk of Infections Associated With JAK Inhibitors in Rheumatoid Arthritis: A Systematic Review and Network Meta-analysis. J Clin Rheumatol. 2022 Mar 1;28(2):e407-e414 PMID:33902098Ackn wledgements:NIL.Disclosure of InterestsNone Declared.

Tomisaku Kawasaki: identified and named Kawasaki disease

"Kawasaki was an icon in the paediatric world,” Jane Burns, professor and director of the Kawasaki Disease Research Centre at the University of California San Diego School of Medicine, told The BMJ. In 1949 he became a staff paediatrician at the Red Cross Hospital outside Tokyo and began to undertake research. ” "Ten years after starting at the Japanese Red Cross Central Hospital (now the Japanese Red Cross Medical Centre) in Tokyo, I examined on 5 January 1961 a boy aged four years and three months with a curious clinical symptom complex I had never seen,” he explained.3 "The patient had a high fever of about two weeks' duration, marked bilateral conjunctival hyperaemia without discharge, reddening dry fissured lips, diffuse redness of the mucous membrane of oral cavity, strawberry like tongue, left non-purulent cervical adenopathy, polymorphous erythema on the body, and marked redness of palms and soles, with indurative oedema of hands and feet following desquamation from the fingertips.”

VACCINATIONS IN PATIENTS WITH CHRONIC INFLAMMATORY DISEASES, PATIENT KNOWLEDGE AND AWARENESS: RESULTS FROM A NORDIC SURVEY

BackgroundPatients with chronic inflammatory diseases (CID) have an increased risk for contracting infections. For patients with rheumatic diseases EULAR recommends protecting them from vaccine-preventable diseases.ObjectivesTo assess the knowledge and awareness of common vaccinations and extent of immunization among patients with CID in Denmark, Finland, Norway, Sweden (Nordics), and to identify gaps between the existing EULAR vaccination recommendations and current practice as experienced by patients.MethodsA structured anonymous online survey for patients with CID ((rheumatological disease (RD), inflammatory bowel disease (IBD) and dermatological diseases (DD)) was conducted in 2022.The survey was answered by 1748 respondents (1031 patients with RD, 543 with IBD and 563 with DD).ResultsAmong respondents, 89% were female and 58% had disease duration of above 10 years. In total, 56% were treated in specialised and 32% in primary care. Majority had ongoing systemic immunosuppressive treatment (IT) (65%). Majority of RD (59%) and IBD (66%) patients were treated in specialised care whereas minority of DD patients (38%) were treated in specialised care.Forty-nine percent (49%) responded that their healthcare professional (HCP) did not inform them about the increased risk of infection – however, 55% of the respondents believed they are somewhat or much more likely to suffer from infections than those without CID or treatment, 33% thought there is no difference and 13% did not know there is a difference.In total 68% of respondents considered it important to get vaccinated due to CID or IT. The number was particularly high in RD group (74%), although 63% stated they had not received any information regarding vaccinations at the start of their treatment.Commonly recommended vaccinations by the HCP were COVID 19 (66%), influenza (63%) and pneumococcal (45%) vaccination. When comparing respondents ≥65 and <65 years, there was a difference in how often the influenza (71% vs. 57%) and pneumococcal (57% vs. 38%), but not COVID 19 vaccination (68% vs. 65%), were recommended. In addition, 74% and 75% of respondents receiving IT were recommended influenza and COVID 19 vaccination, respectively.In total, 22% had their vaccination status checked before initiating treatment;the lowest percentage was in DD (16%) and the highest in RD (25%). However, 44% of respondents received influenza vaccination before initiation of treatment. Moreover, 62% and 74% of respondents received influenza and COVID 19 vaccination while on treatment, respectively.Eighty-six percent (86%) did not receive a vaccination plan in relation to their CID and treatment. Moreover, 64% of the respondents (RD 57%;DD 71% and IBD 66%) did not have vaccination status assessed on a regular basis. Forty-three percent (43%) were dissatisfied with the follow-up of vaccination status by their HCP. Respondents of age ≥65 years were more satisfied than the younger ones (34% vs. 25% very satisfied) and respondents with RD were more satisfied than those with IBD or DD (33% vs. 25% vs. 20%).Forty-four percent (44%) responded that the information on vaccinations related to their CID and treatment was difficult to find and 71% would like to receive more information.The respondents with RD had different level of awareness regarding EULAR vaccination recommendations. The degree of awareness among patients with RD treated with IT are presented in Figure 1.ConclusionThis Nordic survey provides insights on patients' information needs, information sources and own experiences related to recommendations on vaccinations in relation to their CID and IT. The results confirm a gap between patients' expectations and needs vs. the information they actually receive. Our findings demonstrate a need for increased awareness among patients, providers and HCP regarding EULAR vaccination recommendations in patients with RD.Reference[1]Furer V, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2020;79: 9–52.Acknowledgements:NIL.Disclosure of InterestsMeliha C Kapetanovic Grant/research support from: Received independent research grants from Roche and Pfizer, Randeep Mandla Shareholder of: Pfizer, Employee of: Current employee of Pfizer Norway, Maria Seddighzadeh Shareholder of: Pfizer, Employee of: Current employee of Pfizer Sweden, Susanne Thiesen Gren Shareholder of: Pfizer, Employee of: Current employee of Pfizer Denmark, Maaria Palmroth Consultant of: Employee of MedEngine Oy and contractor for Pfizer Oy, Employee of: Contractor for Pfizer Oy, Finland, Dan Henrohn Shareholder of: Pfizer, Employee of: Current employee of Pfizer AB, Sweden, Anne Grete Frostrup Shareholder of: Pfizer, Employee of: Current employee of Pfizer Denmark, Anna-Maria Hiltunen Consultant of: Pfizer. Employee of Nordic Healthcare Group, Jussi Ranta Consultant of: Pfizer. Employee of Nordic Healthcare Group, Anna-Kaisa Asikainen Consultant of: Pfizer. Employee of Nordic Healthcare Group, Veli-Jukka Anttila Speakers bureau: Lectures for Pfizer, MSD, Astellas, Roche, GSK, BMS, Biogen, Sandoz, Gilead, Unimedic Pharma, Boehringer-Ingelheim, Astra-Zeneca, Consultant of: Consultant for Pfizer and MSD.

Therapeutic dilemmas in the management of a patient with long-term rheumatoid arthritis and severe clinical presentation of SARS-CoV-2 infection

Introduction The objective of this case report is to present a clinical course of SARS-CoV-2 infection in a patient with long-term rheumatoid arthritis and concomitant rituximab therapy. Case outline A 58-year-old female patient was diagnosed with seropositive rheumatoid arthritis at the age of 35. She was primarily prescribed chloroquine and glucocorticoid, afterwards methotrexate and biological agent – etanercept. Because of a secondary loss of response, etanercept was switched to rituximab. She had 13 cycles of rituximab and the last was given in June 2020. In December 2020, she was hospitalized due to bilateral pneumonia and respiratory insufficiency. The results of the laboratory analysis revealed anemia, leukocytosis, thrombocytosis, and markedly elevated C-reactive protein, procalcitonin, D-dimer, transaminases. The findings of the chest computed tomography scan were consistent with COVID-19 pneumonia features with accompanying bilateral pleural effusion. The patient was treated with antibiotics, corticosteroids, tocilizumab, hepatoprotective, gastroprotective, oxygen therapy, and parenteral anticoagulant. Three months after recovering from pneumonia, she developed arthritis flare, hence a JAK inhibitor, baricitinib, was started. Low disease activity was achieved with baricitinib monotherapy. Conclusion Due to risk of severe COVID-19, caution may be required when applying immunosuppressive therapy in patients with rheumatic diseases. © 2023, Serbia Medical Society. All rights reserved.

COVID-19 IN PATIENTS WITH RHEUMATIC IMMUNE-MEDIATED INFLAMMATORY DISEASES IN AMERICA: DIFFERENCES AND SIMILARITIES BETWEEN MEXICO AND ARGENTINA

BackgroundPatients with immune-mediated rheumatic diseases (IRD) have poorer outcomes of SARS-CoV-2 infection compared to the general population.ObjectivesTo assess and compare clinical course, severity and complications of SARS-CoV-2 infection in patients with rheumatic immune-mediated inflammatory diseases (IMIDs) from Mexico and Argentina.MethodsData from both national registries, CMR-COVID (Mexico) and SAR-COVID (Argentina), were combined. Briefly, adult IRD patients with SARS-CoV-2 infection were recruited between 08.2020 and 09.2022 in SAR-COVID and between 04.2020 and 06.2022 in CMR-COVID. Sociodemographic data, comorbidities, and DMARDs were recorded, as well as clinical characteristics, complications, and treatment for SARS-CoV-2 infection. Descriptive analysis. Chi square, Fisher, Student T, Mann Whitney U tests and multiple logistic regression analyses were performed.ResultsA total of 3709 patients were included, 1167 (31.5%) from the CMR-COVID registry and 2542 (68.5%) from the SAR-COVID registry. The majority (82.3%) were women, with a mean age of 50.4 years (SD 14.4). The most frequent IRD were rheumatoid arthritis (47.5%) and systemic lupus erythematosus (18.9%). Mexican patients were significantly older, had a higher female predominance and had higher prevalence of rheumatoid arthritis, antiphospholipid syndrome, and axial spondyloarthritis, while the Argentine patients had more frequently psoriatic arthritis and ANCA-associated vasculitis. In both cohorts, approximately 80% were in remission or low disease activity at the time of infection. Mexicans took glucocorticoids (43% vs 37%, p<0.001) and rituximab (6% vs 3%, p<0.001) more frequently. They also reported more comorbidities (48% vs 43%, p=0.012).More than 90% of patients presented symptoms related to SARS-CoV-2 infection. The frequency of hospitalization was comparable between the groups (23.4%), however, the Mexicans had more severe disease (Figure 1) and a higher mortality rate (9.4% vs 4.0%, p<0.0001). After adjusting for risk factors, Mexicans were more likely to die due to COVID-19 (OR 2.2, 95%CI 1.5-3.1).ConclusionIn this cohort of patients with IRD from Mexico and Argentina with SARS-CoV-2 infection, the majority presented symptoms, a quarter were hospitalized and 6% died due to COVID-19. Mexicans presented more severe disease, and after considering risk factors they were two times more likely to die.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsCarolina Ayelen Isnardi Grant/research support from: SAR-COVID is a multi- sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided unrestricted grants. None of them participated or infuenced the development of the project, data collection, analysis, interpretation, or writing the report. They do not have access to the information collected in the database, Deshire Alpizar-Rodriguez: None declared, Marco Ulises Martínez-Martínez: None declared, Rosana Quintana: None declared, Ingrid Eleonora Petkovic: None declared, Sofia Ornella: None declared, Vanessa Viviana Castro Coello: None declared, Edson Velozo: None declared, David Zelaya: None declared, María Severina: None declared, Adriana Karina Cogo: None declared, Romina Nieto: None declared, Dora Aida Pereira: None declared, Iris Jazmin Colunga-Pedraza: None declared, Fedra Irazoque-Palazuelos: None declared, GRETA CRISTINA REYES CORDERO: None declared, Tatiana Sofía Rodriguez-Reyne: None declared, JOSE ANTONIO VELOZ ARANDA: None declared, Cassandra Michele Skinner Taylor: None declared, INGRID MARIBEL JUAREZ MORA: None declared, Beatriz Elena Zazueta Montiel: None declared, Atzintli Martínez: None declared, Cesar Francisco Pacheco Tena: None declared, Guillermo Pons-Estel: None declared.

ASYNCHRONOUS TELECONSULTATION BY WHATSAPP CHATBOT IN CONTROLLED AXIAL SPONDYLOARTHRITIS PATIENTS UNDER BIOLOGICAL THERAPY: PATIENTS' PERSPECTIVE

BackgroundBefore COVID pandemic, rheumatologists were not confident with telehealth for the need to adquire new technology, need of specific training and poorer reimbursement [1]. Two groups of rheumatoid arthritis (RA) patients have been identified in a study of PROMS-based telehealth use (2): the keen and the reluctant. We proposed teleconsultation followup with a whatsapp platform chatbot to our axial spondyloarthritis (AxSPA) patients with controlled disease and we asked them for preferences at the end of the study.ObjectivesTo explore the degree of acceptance of asynchronous telehealth followup with whatsapp platform chatbot among our controlled AxSPA patients under biological therapy, and to search for a patient profile more prone to telehealth consultation.MethodsA prospective study with retrospective control was performed, chosing AxSPA patients under biological therapy with stable disease, visited in our centre from 01/01 to 30/11/2021. We recruited 62 patients, but finally include 60 (2 quit for home moving or personal reasons). We offered them two teleconsultation visits (using their personal mobile), every four months, and a presential final visit one year after inclusion. The chatbot sends PROMS (BASDAI, VAS for patient global disease assessment, ASDAS, and 3 questions for extraarticular disease), and feedback and schedule for the following visits. In the case of lab test or PROMs deviation or when the patient asks for contact, he/she is phoned by nurse/doctor who solves the question and/or arranges an additional presential visit. We collect patient and disease characteristics (age, gender, educational level, employment, disease activity, duration and treatments), and patient´s satisfation and preferences in the final visit.ResultsWe included 60 patients (83,3% men), mean aged 48,22 years (SD 12,128), 36% under 45 years at inclusion. 27% had received primary, 33.9% secondary and 39% tertiary education. 83.3% were active working and only 10 patients were jobless or retired. They were Ankylosing Spondylitis (AS) (90%), HLA B27 positive (85%) with longstanding disease (mean 23 years, SD 12,8), and were receiving the first (71%), or the second (23%) biological therapy (51,7% tapered anti-TNF). 50% were never smokers and 70% presented no remarkable comorbidity;25% presented peripheral impairment, and over 40% extraarticular manifestations.At inclusion 93,3% were at remission/LDA by ASDAS/BASDAI-RCP and 4 patients were considered clinically controlled in spite of higher scores. At followup 3 patients with reduced dose needed to increase to standard dose of biological drug, with no other need of treatment change. There was no worsening from basal to final visits according BASDAI, BASFI, ASDAS-RCP or AsQOL.Patients final VAS score (1-10) assessment of telehealth consultation was very high: mean 9,14 (DS 1,498);91.7% ≥ 8 and 76.7% ≥ 9.83,3% preferred telehealth followup. There was a trend towards telehealth preferences in higher educational levels, and active working (86% vs 70%) but not statistically significant. We found no correlation with gender, age and disease characteristics tested.ConclusionAsynchronous teleconsultation seems promising, not inferior to presential consultation and preferred for follow-up by our AxSpa patients with stable disease with biological drugs. We met some "reluctant patients”, that were more inactive working and with lower educational levels, but the differences were not significant. Further reserarch is needed with this telehealth model in other age and disease populations (RA), in order to characterize the reluctant and keen patients.References[1]Muehlensiepen F, et al. Acceptance of Telerheumatology by Rheumatologists and General Practitioners in Germany: Nationwide Cross-sectional Survey Study. J Med Internet Res. 2021 Mar 29;23(3):e23742.[2]Knudsen LR, et al. Experiences With Telehealth Followup in Patients With Rheumatoid Arthritis: A Qualitative Interview Study. Arthritis Care Res (Hoboken). 2018 Sep;70(9):1366-1372.AcknowledgementsGrupo INNOBIDE.Disclosure of I terestsNone Declared.

ADHERENCE TO BIOLOGIC THERAPIES IN INFLAMMATORY RHEUMATIC DISEASES: INFLUENCE OF ROUTE OF ADMINISTRATION

BackgroundInflammatory rheumatic diseases are a debilitating disease affecting the joints and periarticular structures and leading, more or less rapidly, to cartilage and bone destruction. It is a major source of chronic pain and physical, psychological, and social disability, it affect approximately 1% of the world's population [1]. For more than 20 years, biotherapies have revolutionized the treatment of these inflammatory diseases and have largely contributed to the improvement of their prognosis [2]. Adherence to biologic therapies conditions the effectiveness of the treatments then the improvement of patients' quality of life [3].ObjectivesTo evaluate and compare adherence to biologic disease-modifying antirheumatic drugs (bDMARDs) according to the route of administration and the molecule used (Infliximab, Tocilizumab, Etanercept, Adalimumab, Certolizumab, and Golimumab) in patients with inflammatory rheumatic diseases.MethodsThis is a descriptive cross-sectional study with repeated data collection, bi-centric carried out in the rheumatology departments and outpatient clinics at Charles Nicolle Hospital and Rabta Hospital in Tunis and conducted over a period of 01 year and 02 months between 02/02/2021 and 30/04/2022. 71 adult patients with rheumatoid arthritis, spondyloarthritis or juvenile idiopathic arthritis were recruited, their adherence rate in the last 3 months before inclusion should be ≥80%. The collection of socio-demographic, clinical and therapeutic data was established with the help of a pre-established form, from medical files completed by questioning the patients during a direct interview or through a telephone communication. Adherence rate was calculated by determining the ratio of treatments cures (number of biologic injections taken during a year divided by the number of annual biologic injections prescribed).ResultsWithin the study population, adherence was estimated at 85.9%;in the group of patients using intravenous biotherapy was 82.1% (Infliximab 86%, Tocilizumab 75% p=0.04) and in the group of patients using subcutaneous treatment was 89.9% (Golimumab 94%, Etanercept 92%, Certolizumab 89%, Adalimumab 87% p=0.3). Adherence to biologic therapy was significantly higher in the subcutaneous group than in the intravenous group (p=0.01). The causes of poor adherence presented by the patients in this study were: stock-outs of biological treatment and delay in renewal by the national health insurance (CNAM) in thirty-eight cases (54%p<0.001), intercurrent infections in thirty-three cases (46% p=0.005) and the COVID 19 pandemic and its consequences in thirty patients (42%,p=0.28).ConclusionAdherence to biologic treatment is influenced by the route of administration, drugs type, intercurrent infections and drugs availability. All this factors must be treated to improve therapeutic adherence then the efficiency of the biologic therapy which conditions the preservation of physical capacities and an improvement in the quality of life.References[1]Adhésion médicamenteuse et représentations des patients atteints de rhumatisme inflammatoire chronique sous biothérapie: étude ADREP'RI.: 84. Betegnie AL.[2]2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. Singh JA, Saag KG, Bridges SL, Akl EA et al. janv 2016;68(1):1‑26.[3]Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. sept 2010;10(9):1367‑78.[4]Adherence of rheumatoid arthritis patients to biologic disease-modifying antirheumatic drugs: a cross-sectional study. Mena-Vazquez N, Manrique-Arija S, Yunquera-Romero L, Ureña-Garnica I, Rojas-Gimenez et al.. Rheumatol Int [Internet]. oct 2017 [cité 30 oct 2022];37(10):1709‑18.[5]Adherence to Anti-Tumor Necrosis Factor Therapy Administered Subcutaneously and Associated Factors in Patients with Rheumatoid Arthritis. Salaffi F, Carotti M, Di Carlo M, Farah S, Gutierrez M. J Clin Rheumatol. déc 2015;21(8):419‑25.Acknowledgements:N L.Disclosure of InterestsNone Declared.

ASYNCHRONOUS TELECONSULTATION BY WHATSAPP CHATBOT IN CONTROLLED AXIAL SPONDYLOARTHRITIS (SPA) PATIENTS UNDER BIOLOGICAL THERAPY: CLINICAL RESULTS OF A SINGLE CENTER

BackgroundThe use of telehealth in the control of rheumatic diseases had been scarce, but COVID pandemic forced to try alternatives to classic face-to-face consultation, and an overflow of telehealth consultations appeared, mainly synchronous (phone, video calls), and finally asynchronous. We try to demonstrate that asynchronous WhatsApp teleconsultation is a good alternative, at least for followup of patients that find it difficult to attend face-to-face visits. We chose axial spondyloarthritis (AxSPA) patients under biological therapy with controlled disease and we proposed teleconsultation with a WhatsApp platform chatbot created for this purpose. The chatbot sends PROMS (BASDAI, VAS for patient global disease assessment, ASDAs, and 3 questions for extraarticular disease), and receive feedback and schedule for the following visits.ObjectivesTo prove that teleconsultation through WhatsApp platform is not inferior to face-to-face consultation in terms of maintaining axial SPA patients disease controlled.MethodsProspective study with retrospective control of patients diagnosed of Axial SPA, fulfilling ASAS criteria and with stable disease under biological therapy for the previous year, recruited from 01 jan to 30 nov 2021. We recruited 62 patients, but two of them gave up (personal reasons, one moved to other region), so we finally include 60 patients. We offer them two teleconsultation visits with their personal mobile device, every four months, and a face-to-face final visit one year after inclusion. In the case of lab test or PROMs deviation or when the patient asks for contact (possible via WhatsApp) he/she is called up by the person in charge (nurse/doctor) that solves the question and arranges an additional presential visit if needed. We consider disease controlled if BASDAI <4, ASDAS < 2,1 or if in rheumatologist´s opinion there is no need to change treatment. We collect patient and disease information (age, gender, employment, characteristics of the disease, previous and actual treatment), activity (BASDAI, PCR, ASDAS), physical function (BASFI), and Quality of life (AsQol).Results60 patients (50 men, 83,3%) were included, mean aged 48,22 years (SD 12,128), 36% were under 45 years at the time of inclusion. They were mostly Ankylosing Spondylitis (AS) (90%;only 6 non radiographic SPA), positive HLA B27 (85%) and with longstanding disease (mean 23 years, SD 12,8), and only 6 patients less than five years. 25% had peripheral impairment (arthritis/dactylitis/enthesitis), and more than 40% presented extraarticular manifestations, mainly psoriasis (26,7%) and uveitis (21%)71,7% were under their first biological (TNF inhibitor, mostly adalimumab), 23,3% were refractory to the first, and 3 patients to at least two biologicals. 51,7% of patients were treated with tapered dose of TNF inhibitors. At inclusion 93,3 % presented remission/LDA by ASDAS/BASDAI-RCP. Only 4 patients included presented higher activity scores but were considered clinically controlled.Table 1.We did not find meaningful clinical differences between basal to final visits in BASDAI, BASFI, ASDAS-RCP or AsQOL.3 patients with reduced dose of biological drug needed to increase to standard dose with no other need to treatment adjustment.ConclusionWe consider asynchronous teleconsultation is promising, and not inferior to face to face consultation in terms of keeping disease control and quality of life, especially for follow-up in patients with stable rheumatic disease, The clinical results presented here are consistent with this considerations.AcknowledgementsGrupo INNOBIDE.Disclosure of InterestsNone Declared.

SYSTEMIC SCLEROSIS AND COVID-19 VACCINE-ASSOCIATED DELAYED ADVERSE EVENTS: INSIGHTS FROM THE COVAD-2 STUDY

BackgroundWe have previously reported short term safety of the COVID-19 vaccination in patients with Systemic sclerosis (SSc) but delayed adverse events (ADEs) (occurring >7 days post-vaccination) are poorly characterized in this rare yet vulnerable disease group.ObjectivesWe analyzed delayed COVID-19 vaccine-related ADEs among patients with SSc, other systemic autoimmune and inflammatory disorders (SAIDs) and healthy controls (HC) using data from the ongoing 2nd global COVID-19 Vaccination in Autoimmune Diseases (COVAD-2) study [1].MethodsThe COVAD-2 study was a cross-sectional, patient self-reporting e-survey utilizing an extensively validated, pilot tested questionnaire, translated into 19 languages, circulated by a group of 157 physicians across 106 countries from February to June 2022.We captured data on demographics, SSc/SAID disease characteristics (including skin subset, treatment history and self-reported disease activity), autoimmune and non-autoimmune comorbidities, COVID-19 infection history and course, and vaccination details including delayed ADEs as defined by the CDC.Delayed ADEs were categorized into local injection site pain/soreness;minor and major systemic ADEs, and hospitalizations. We descriptively analyzed the risk factors for overall and specific ADEs in SSc and SAIDs, and further triangulated clinically significant variables in binominal logistic regression analysis with adjustment for age, gender, ethnicity, comorbidity, and immunosuppressive therapy to analyze the survey responses.ResultsFrom among 17 612 respondents, 10 041 patients (median age 51 (18-58) years, 73.4% females, 44.9% Caucasians) vaccinated against COVID-19 at least once (excluding incomplete responses and trial participants) were included for analysis. Of these, 2.6 % (n=258) had SSc, 63.7% other SAIDs, and 33.7% were HCs. BNT162b2 Pfizer (69.4%) was the most administered vaccine, followed by MRNA-1273 Moderna (32.25%) and ChadOx1 nCOV-19 Oxford/AstraZeneca (12.4%) vaccines.Among the patients with SSc, 18.9% reported minor while 8.5% experienced major delayed ADEs, and 4.6% reported hospitalization. These values were comparable to those of the ADEs reported in other SAIDs and HCs. Patients with SSc reported higher frequency of difficulty in breathing than HCs [OR=2.3 (1.0-5.1), p=0.042].Individuals receiving Oxford/AstraZeneca reported more minor ADEs [OR=2.5 (1.0-6.0), p=0.045];whereas patients receiving Moderna were less likely to develop myalgia and body ache [OR=0.1 (0.02-1.0), p=0.047 and OR=0.2 (0.05-1.0), p=0.044 respectively].Patients with diffuse cutaneous SSc experienced minor ADEs and specifically fatigue more frequently [OR=2.1 (1.1-4.4), p=0.036, and OR=3.9 (1.3-11.7), p=0.015] than those with limited cutaneous SSc. Self-reported active disease pre-vaccination did not confer any increased risk of vaccine ADEs in the adjusted analysis. Unlike our previous observations in myositis, autoimmune and non-autoimmune comorbidities did not affect the risk of delayed ADEs in SSc. SSc patients with concomitant myositis reported myalgia [OR=3.4 (1.1-10.7), p=0.035] more frequently, while those with thyroid disorders were more prone to report a higher frequency of joint pain [OR=5.5 (1.5-20.2), p=0.009] and dizziness [OR=5.9 (1.3-27.6), p=0.024] than patients with SSc alone. Patients with SSc-interstitial lung disease did not report increased frequency of ADEs.ConclusionA diagnosis of SSc did not confer a higher risk of delayed post COVID-19 vaccine-related ADEs than other SAIDs and HCs. Diffuse cutaneous phenotype and certain co-existing autoimmune conditions including myositis and thyroid disease can increase the risk of minor ADEs. These patients may benefit from pre-vaccination counselling, close monitoring, and early initiation of appropriate care in the post COVID-19 vaccination period.Reference[1]Fazal ZZ, Sen P, Joshi M, Ravichandran N, Lilleker JB, et al. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022 Dec;42(12):2151-2158AcknowledgementsCOVAD Study Team.Disclosure of InterestsBo dana Doskaliuk: None declared, Parikshit Sen: None declared, Mrudula Joshi: None declared, Naveen Ravichandran: None declared, Ai Lyn Tan Speakers bureau: Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Samuel Katsuyuki Shinjo: None declared, Sreoshy Saha: None declared, Nelly Ziade Speakers bureau: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis,Boehringer Ingelheim, Janssen, and Pierre Fabre, Consultant of: Pfizer, Roche, Abbvie, Eli Lilly,NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre, Grant/research support from: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and.Pierre Fabre, Tulika Chatterjee: None declared, Masataka Kuwana: None declared, Johannes Knitza: None declared, Oliver Distler Speakers bureau: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur, Consultant of: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur, Grant/research support from: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur, Rohit Aggarwal Consultant of: Mallinckrodt, Octapharma, CSL Behring, Bristol Myers-Squibb, EMD Serono, Kezar, Pfizer, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim, Corbus, Janssen, Kyverna, Roivant, Merck, Galapagos, Actigraph, Abbvie, Scipher, Horizontal Therapeutics, Teva, Biogen, Beigene, ANI Pharmaceutical, Nuvig, Capella, CabalettaBio, Grant/research support from: Mallinckrodt, Pfizer, Bristol Myers-Squibb, Q32, EMD Serono, Janssen, Boehringer Ingelheim (BI), Ashima Makol: None declared, Latika Gupta: None declared, Vikas Agarwal: None declared.